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Titolo:
A randomised phase II study of oxaliplatin alone versus oxaliplatin combined with 5-fluorouracil and folinic acid (Mayo Clinic regimen) in previouslyuntreated metastatic colorectal cancer patients
Autore:
Comba, AZ; Blajman, C; Richardet, E; Bella, S; Vilanova, M; Coppola, F; Van Kooten, M; Rodger, J; Giglio, R; Balbiani, L; Perazzo, F; Montiel, M; Chacon, M; Pujol, F; Mickiewicz, E; Cazap, E; Recondo, G; Lastiri, F; Simon, J; Wasserman, E; Schmilovich, A;
Indirizzi:
Hosp Zubizarreta, Buenos Aires, DF, Argentina Hosp Zubizarreta Buenos Aires DF Argentina , Buenos Aires, DF, Argentina Hosp Italiano, Cordoba, Argentina Hosp Italiano Cordoba ArgentinaHosp Italiano, Cordoba, Argentina Clin Independencia, Buenos Aires, DF, Argentina Clin Independencia BuenosAires DF Argentina Buenos Aires, DF, Argentina Hosp Aleman, Buenos Aires, DF, Argentina Hosp Aleman Buenos Aires DF Argentina leman, Buenos Aires, DF, Argentina Inst Alexander Fleming, Buenos Aires, DF, Argentina Inst Alexander Fleming Buenos Aires DF Argentina os Aires, DF, Argentina Inst Estevez, Buenos Aires, DF, Argentina Inst Estevez Buenos Aires DF Argentina evez, Buenos Aires, DF, Argentina Inst Angel Roffo, Buenos Aires, DF, Argentina Inst Angel Roffo Buenos Aires DF Argentina , Buenos Aires, DF, Argentina Hosp Municipal Oncol, Buenos Aires, DF, Argentina Hosp Municipal Oncol Buenos Aires DF Argentina enos Aires, DF, Argentina CEMIC, Buenos Aires, DF, Argentina CEMIC Buenos Aires DF ArgentinaCEMIC, Buenos Aires, DF, Argentina Acad Nacl Med, Dept Bioestadiast, Buenos Aires, DF, Argentina Acad Nacl Med Buenos Aires DF Argentina ast, Buenos Aires, DF, Argentina Cvitkovic & Associates Consultants, Buenos Aires, DF, Argentina Cvitkovic & Associates Consultants Buenos Aires DF Argentina , Argentina Lab Searle, Buenos Aires, DF, Argentina Lab Searle Buenos Aires DF Argentina Searle, Buenos Aires, DF, Argentina
Titolo Testata:
EUROPEAN JOURNAL OF CANCER
fascicolo: 8, volume: 37, anno: 2001,
pagine: 1006 - 1013
SICI:
0959-8049(200105)37:8<1006:ARPISO>2.0.ZU;2-M
Fonte:
ISI
Lingua:
ENG
Soggetto:
FIRST-LINE TREATMENT; CONTINUOUS-INFUSION; FLUOROURACIL; LEUCOVORIN; TRIAL; BOLUS; CARCINOMA;
Keywords:
colorectal; chemotherapy; oxaliplatin; Mayo clinic regimen; randomised;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
23
Recensione:
Indirizzi per estratti:
Indirizzo: Wasserman, E Aguilar 2493,3A, Buenos Aires, DF, Argentina Aguilar 2493,3ABuenos Aires DF Argentina es, DF, Argentina
Citazione:
A.Z. Comba et al., "A randomised phase II study of oxaliplatin alone versus oxaliplatin combined with 5-fluorouracil and folinic acid (Mayo Clinic regimen) in previouslyuntreated metastatic colorectal cancer patients", EUR J CANC, 37(8), 2001, pp. 1006-1013

Abstract

The aim of this study was to examine the efficacy and safety of both oxaliplatin as a single agent and oxaliplatin in combination with daily x 5 bolus 5-fluorouracil and folinic acid (5-FU/FA, Mayo clinic regimen) in the first-line treatment of metastatic colorectal cancer (CRC) patients. 73 advanced CRC patients were randomised to receive either oxaliplatin 85 mg/m(2) every 2 weeks (35 patients), or the same treatment combined with 5-FU 425 mg/m(2)/day and FA 20 mg/m(2)/day x 5 days every 4 weeks (38 patients). Treatment was continued until disease progression or unacceptable toxicity. All patients had documented inoperable disease and no previous chemotherapy for advanced disease. Based on the investigators' assessment of best response, objective response rate was 9% (95% confidence interval (CI) 2-24%) in the oxaliplatin arm, and 45% (95% CI 27-64%) in the oxaliplatin + 5-FU/FA arm. Median progression-free survival(PFS) was 2 months (95% CI 1.7-2.4 months) in the oxaliplatin arm and 3.9 months (95% CI 2.9-5 months) in the oxaliplatin + 5-FU/FA arm. Severe neutropenia was seen in 23% of patients in the oxaliplatin + 5-FU/FA arm, and none in the oxaliplatin arm. There were two treatment-related deaths, both in the oxaliplatin + 5-FU/FA arm. In the oxaliplatin + 5-FU/FA arm, severe diarrhoea, vomiting and stomatitis were seen in 34, 14 and 14% of the patients, respectively. In conclusion, oxaliplatin at a dose of 85 mg/m(2) given every 2 weeks was well tolerated and has limited activity in metastatic CRC, while the combination of this treatment with the full-dose Mayo clinic regimen (5-FU bolus 425 mg/m(2)/day + FA 20 mg/m(2)/day x 5 days every 4 weeks), although active, was unfeasible due to a high level of myelosuppression and gastrointestinal toxicity. Alternative lower dosing or other regimens are to be explored to ascertain the value of bolus 5-FU/FA combined with oxaliplatin. (C) 2001 Published by Elsevier Science Ltd. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/01/20 alle ore 15:54:28